Systems, apparatuses, and methods for correcting a bone defect

ABSTRACT

An implant having a unitary body includes an intramedullary portion and an extramedullary portion. The intramedullary portion is sized and structured to be received within an intramedullary canal of a first bone and defines a longitudinal axis. The extramedullary portion includes a surface defining an axis that is disposed at an angle with respect to the longitudinal axis. An aperture defined along the extramedullary portion is sized and configured to receive a fastener therein for coupling the extramedullary portion of the implant to a second bone.

FIELD

This disclosure relates generally to medical devices, and morespecifically to implants for correcting bone deformity.

BACKGROUND

Tailor's bunion, or bunionette, is a condition of the human footresulting in the inflammation of the fifth metatarsal bone at the baseof the smallest toe. Tailor's bunions have proven to be difficult torepair due to the small size of the fifth metatarsal, especially at thedistal metaphysis where many surgeons would prefer to make osteotomies.Further, the small cross-sectional area of the fifth metatarsal makeseven the smallest screw difficult to place for a shifting head osteotomy(e.g., distal chevron, distal transverse cut), as the screws themselvestake up a large portion of the remaining bone-on-bone contact.

SUMMARY

In some embodiments, an implant having a unitary body includes anintramedullary portion and an extramedullary portion. The intramedullaryportion is sized and structured to be received within an intramedullarycanal of a first bone and defines a longitudinal axis. Theextramedullary portion includes a surface defining an axis that isdisposed at an angle with respect to the longitudinal axis. An aperturedefined along the extramedullary portion is sized and configured toreceive a fastener therein for coupling the extramedullary portion ofthe implant to a second bone.

In some embodiments, the fastener is one of a locking fastener and anon-locking fastener.

In some embodiments, the extramedullary portion defining the apertureincludes surface features permitting a fastener to be received at aplurality of angles relative to a central axis defined by the aperture.

In some embodiments, the surface features include a plurality ofintermittent threads.

In some embodiments, the central axis defined by the aperture ispositioned at an oblique angle with respect to the longitudinal axisdefined by the intramedullary portion of the implant.

In some embodiments, the intramedullary portion has a circularcross-sectional geometry.

In some embodiments, a first end of the intramedullary portion of theimplant tapers to a blunt end.

In some embodiments, a first end of the intramedullary portion of theimplant tapers to a blade.

In some embodiments, the extramedullary portion of the implant isenlarged with respect to the intramedullary portion.

In some embodiments, the intramedullary portion of the implant includesone or more surface features disposed thereon for securing the implantwithin an intramedullary canal of a first bone.

In some embodiments, the surface features are selected from a groupconsisting of threads, splines, fins, and knurling.

In some embodiments, the first bone is a first bone is a first bonefragment formed from a third bone, and the second bone is a second bonefragment formed from the third bone.

In some embodiments, the first bone and the second bone are two adjacentbones of a joint.

In some embodiments, a system includes an implant and a fastener. Theimplant has a unitary body including an intramedullary portion and anextramedullary portion. The intramedullary portion is sized andstructured to be received within an intramedullary canal of a first boneand defines a longitudinal axis. The extramedullary portion isstructured to be coupled to a second bone. An aperture defined by theextramedullary portion includes a surface defining an axis that isdisposed at an angle with respect to the longitudinal axis. The fasteneris sized and structured to be received within the aperture defined bythe extramedullary portion of the implant.

In some embodiments, a central axis defined by the aperture ispositioned at an oblique angle with respect to the longitudinal axisdefined by the intramedullary portion of the implant.

In some embodiments, the surface of the extramedullary portion of theimplant includes a planar surface.

In some embodiments, the fastener is one of a locking screw and anon-locking screw.

In some embodiments, the system includes an inserter having a bodyextending from a first end to a second end. At least one of the firstend and the second end defines a pocket that is interconnected with ahole.

In some embodiments, the pocket is sized, dimensioned, and structured toreceive at least a portion of the extramedullary portion therein suchthat, when the extramedullary portion of the implant is received withinthe pocket, the hole defined by the inserter aligns with the aperturedefined by the implant.

In some embodiments, the system includes a guide having a body extendingfrom a first end to a second end. A hole extends through the body fromthe first end to the second end, and at least one of the first end andthe second end is at least partially threaded for engaging a threaddefined by the aperture defined by the implant.

In some embodiments, a treatment method includes forming a longitudinalhole in a first bone; inserting an intramedullary portion of an implantinto the longitudinal hole; forming a hole in a second bone based on aposition of an aperture defined by an extramedullary portion of theimplant relative to the second bone; and inserting a fastener throughthe aperture and into the second bone to couple the extramedullaryportion of the implant to the second bone. The intramedullary portion ofthe implant defines a first longitudinal axis, and the extramedullaryportion has a surface defining an axis that is disposed at an angle withrespect to the longitudinal axis defined by the intramedullary portion.

In some embodiments, forming the hole in the second bone includesinserting a cutting tool into a guide hole defined by a guide, andfurther inserting the cutting tool into the guide hole until the cuttingtool engages the second bone. The guide is coupled to the implant suchthat the guide hole is aligned with the aperture defined by the implant.

In some embodiments, the method includes disengaging the guide from theimplant prior to inserting the fastener through the aperture.

In some embodiments, the method includes disengaging an insertion toolfrom the implant prior to inserting the fastener through the aperture.

In some embodiments, the longitudinal hole is formed using a broach.

In some embodiments, the first bone is a first bone segment formed froma third bone, the second bone is a second bone segment formed from thethird bone, and the method includes performing an osteotomy on the thirdbone to form the first bone segment and the second bone segment.

In some embodiments, the third bone is a fifth metatarsal.

In some embodiments, the angle between the axis defined by the surfaceand the longitudinal axis is a right angle.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of one example of an implant in accordance withsome embodiments;

FIG. 2 is a side view of the implant illustrated in FIG. 1 in accordancewith some embodiments;

FIG. 3 is a detail view of the enlarged head of an extramedullaryportion of the implant illustrated in FIG. 1 in accordance with someembodiments;

FIG. 4 is a plan view of another example of an implant in accordancewith some embodiments;

FIG. 5 is a side view of the implant illustrated in FIG. 4 in accordancewith some embodiments;

FIG. 6 is a bottom-side plan view of one example of an inserter inaccordance with some embodiments;

FIG. 7 is a side view of the inserter illustrated in FIG. 6 inaccordance with some embodiments;

FIG. 8 is a top-side plan view of the inserter illustrated in FIG. 6 inaccordance with some embodiments;

FIG. 9 is a detailed view of the engagement end of an inserter, takenalong line 9-9 in FIG. 7, in accordance with some embodiments;

FIG. 10 is a cross-sectional view, taken along line 10-10 in FIG. 8, inaccordance with some embodiments;

FIG. 11 is a side view of one example of a guide tool in accordance withsome embodiments;

FIG. 12 is a front side plan view of the guide tool illustrated in FIG.11 in accordance with some embodiments;

FIG. 13 is a sectional view of the guide tool illustrated in FIG. 11,taken along line 13-13 in FIG. 12, in accordance with some embodiments;

FIG. 14 is a top-side plan view of one example of a broach in accordancewith some embodiments;

FIG. 15 is a side view of the broach illustrated in FIG. 14 inaccordance with some embodiments;

FIG. 16 is a bottom-side plan view of the broach illustrated in FIG. 14in accordance with some embodiments;

FIG. 17 is a side view of one example of a broach insert for a broach inaccordance with some embodiments;

FIG. 18 is a top-side plan view of the broach insert shown in FIG. 17 inaccordance with some embodiments;

FIG. 19 is an isometric view of an assembly of an implant, an inserter,and a guide in accordance with some embodiments;

FIG. 20 is a flow diagram of one example of a method of treatment inaccordance with some embodiments;

FIGS. 20A-20H illustrate various stages of the method of treatment inaccordance with FIG. 20; and

FIG. 21 illustrates one example of an implant joining two bone segments,sections, or fragments in accordance with some embodiments.

DESCRIPTION

This description of the exemplary embodiments is to be read inconnection with the accompanying drawings, which are to be consideredpart of the entire written description. In the description, relativeterms such as “lower,” “upper,” “horizontal,” “vertical,”, “above,”“below,” “up,” “down,” “top” and “bottom” as well as derivative thereof(e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should beconstrued to refer to the orientation as then described or as shown inthe drawing under discussion. These relative terms are for convenienceof description and do not require that the apparatus be constructed oroperated in a particular orientation. Terms concerning attachments,coupling and the like, such as “connected” and “interconnected,” referto a relationship wherein structures are secured or attached to oneanother either directly or indirectly through intervening structures, aswell as both movable or rigid attachments or relationships, unlessexpressly described otherwise. In the various drawings, like referencenumerals indicate like items, unless expressly stated otherwise.

This disclosure provides implants, systems for installing the implants,and treatment methods for minimally invasive correction of Tailor'sbunion (or of an analogous deformity in another joint). Although thedrawings show application of the implant, inserter, and guide fortreating a fifth metatarsal for the correction of Tailor's bunion, theimplant, systems, and methods can be sized, configured, and tailored totreat other bones. For example, while the implants, systems, and methodsmay be described as being used to couple together first and secondfragments or segments formed from a single bone, it should be understoodthat the implants, systems and methods may be used to extend across ajoint thereby coupling together two adjacent and/or distinct bones(e.g., a metatarsal and a phalange). As such, the terms “first bone” and“second bone” may refer to two naturally distinct bones (e.g., ametatarsal and a phalange) and/or to two sections, portions, orfragments operatively formed from a single bone (e.g., a distal fragmentand a proximal fragment formed from a metatarsal).

FIGS. 1-3 show a first example of the implant 100. FIG. 1 is a plan viewof the implant 100, and FIG. 2 is a medial (or lateral) side view of theimplant 100 of FIG. 1.

Referring to FIGS. 1-3, the implant 100 is illustrated having a unitarybody including an intramedullary portion 110 connected to anextramedullary portion 130. The unitary body of implant 100 isconfigured to attach a first bone section, segment, or fragment to asecond bone segment, section, or fragment. For example, implant 100 maybe used to attach a proximal bone segment or fragment PF to a distalbone segment or fragment DF as best seen in FIG. 21. It should beunderstood that the implant 100 can be used on either left or rightfoot.

The intramedullary portion 110 defines a first longitudinal axis 120,which can be a central axis. The intramedullary portion 110 isconfigured for insertion into the first bone section (e.g., proximalfragment PF shown in FIG. 21). As best seen in FIGS. 1 and 2,intramedullary portion 110 may have a cylindrical geometricconfiguration with a one or more tapers or bevels 104 at first end(e.g., distal or insertion end) 102 to facilitate insertion of theintramedullary portion 110 into an intramedullary canal formed in a bonesegment or fragment as will be discussed in greater detail herein. Insome embodiments, the taper or bevel 104 terminates in a blunted tip106. Although the cross-sectional geometry of intramedullary portion 110is shown as being cylindrical, one of ordinary skill in the art willunderstand that the cross-sectional geometry of intramedullary portion110 may be polygonal (e.g., triangular, rectangular, pentagonal, etc.)and/or include one or more protrusions or flat surfaces formed thereonto resist rotation of the implant 110 relative to the first bone segmentor fragment. In some embodiments, the intramedullary portion 110 may becompletely or partially threaded. In some embodiments, theintramedullary portion 110 may include one or more fins or protrusionsextending outwardly therefrom to resist rotation of the implant 100relative to the bone segment, section, or fragment.

The extramedullary portion 130 includes a bone contacting side or face132 configured to abut a surface of a second bone section (e.g., adistal fragment DF as shown in FIG. 21). As best seen in FIG. 1,extramedullary portion 130 includes an enlarged head 134 defining afastener aperture 136. In some embodiments, the enlarged head 134 has acircular geometry, although one of ordinary skill in the art willunderstand that enlarged head 134 may have other shapes. The at leastone fastener aperture 136 defined by enlarged head 134 of extramedullaryportion 130 defines an aperture axis 138 as best seen in FIG. 2.Fastener aperture 136 is sized and configured to receive a bone fastener(e.g., an “Ortholoc® 3Di™” locking screw sold by Wright MedicalTechnology, Inc. of Memphis, Tenn.), which may be used to secure theextramedullary portion 130 to the second bone section. For example, insome embodiments, the fastener aperture 136 includes a number ofintermittent threads 137 that are formed by first tapping the aperture136 and then transversely cutting through the threads to form the threadsegments or intermittent threads 137 as best seen in FIGS. 1 and 3. Insome embodiments, six transverse cuts are made to form the intermittentthreads 137; however, one of ordinary skill in the art will understandthat fewer or more transverse cuts can be made.

In some embodiments, the aperture axis 138 is oriented obliquelyrelative to the first longitudinal axis 120 as best seen in FIG. 2. Inother embodiments (not shown), the aperture axis 138 is from about 90degrees to about 180 degrees from the first longitudinal axis 120. Forexample, in some embodiments, the aperture axis 138 is orientedorthogonal to the first longitudinal axis 120.

The bone fastener may be disposed transversely or obliquely, relative tothe fastener aperture 136. In some embodiments, polyaxial screws can beinserted at an angle of 0.0 to about 15 degrees with respect to thetransverse axis of the fastener aperture 136. In some embodiments,polyaxial screws such as 3Di locking screws or non-locking screws soldby Wright Medical Technology, Inc. of Memphis, Tenn. may be utilized. Aswill be understood by a person of ordinary skill in the art, polyaxialscrews may be inserted parallel to aperture axis 138 or at an angle(e.g., up to 15 degrees) relative to aperture axis 138.

As best seen in FIG. 2, a flat surface 140 is formed along a face ofextramedullary portion 130 that is disposed opposite bone contactingside or face 132 and extends along at least a portion of the length ofintramedullary portion 110. In some embodiments, flat surface 140 isdisposed parallel to bone contacting side or face, which is disposed atan angle with respect longitudinal axis 120 defined by intramedullaryportion 110. Put another way, in some embodiments, bone contacting sideor face 132 and flat surface 140 are not arranged orthogonal or parallelto longitudinal axis 120, although one of ordinary skill in the art willunderstand that such arrangements in which bone contacting side or face132 and flat surface 140 are positioned parallel to longitudinal axisare contemplated. In some embodiments, the bone contacting side or faceis positioned at an angle of 15 degrees (or 165 degrees) relative tolongitudinal axis 120 for correcting the valgus of the fifth metatarsal(metatarsus quintus valgus) at the level of the metatarsal head. In someembodiments, flat surface 140 includes first and second portions, whichthemselves may be disposed at angles relative to one another (i.e., thefirst and second portions are not co-planar).

FIGS. 4-5 illustrate another example of an implant 200 in accordancewith some embodiments. FIG. 4 is a plan view of the implant 200, andFIG. 5 is a medial (or lateral) side view of the implant 200 of FIG. 4.

Like implant 100, implant 200 may have a unitary body including anintramedullary portion 210 that transitions into an extramedullaryportion 230. Implant 200 is configured to attach a first bone section toa second bone section and can be used on either the left or the rightfoot.

The intramedullary portion 210 defines a first longitudinal axis 220,which can be a central axis, extending from first end (e.g., aninsertion end) 206 and continuing to extramedullary portion 230.Intramedullary portion 210 may have a cylindrical geometricconfiguration with a one or more tapers or bevels 204 at first end 202to facilitate insertion of the intramedullary portion 210 into bonesegment as will be discussed in greater detail herein. In someembodiments taper or bevel terminates at a blade tip 206 that is morenarrow and pointed than blunted tip 106. Although the cross-sectionalgeometry of intramedullary portion 210 is shown as being cylindrical,one of ordinary skill in the art will understand that thecross-sectional geometry of intramedullary portion 210 may be polygonaland/or include one or more protrusions, extensions, flat surfaces, orother anti-rotation features formed thereon to resist rotation of theimplant 210 relative to a bone when implanted. Further, as discussedabove with respect to implant 100, intramedullary portion 210 may becompletely or partially threaded, or the intramedullary may includingone or more fins or other protrusions extending from an externallongitudinal surface thereof to engage the surrounding bone onceimplanted to resist rotation, improve fixation, and/or improve bonepurchase.

Extramedullary portion 230 includes a bone contacting side or face 232configured to abut a surface of the second bone section. As best seen inFIG. 4, extramedullary portion 230 includes an enlarged head 234defining a fastener aperture 236 therethrough. Enlarged head 234 isshown with a circular geometry; however, one of ordinary skill in theart will understand that enlarged head 234 may have other geometricalshapes. The at least one fastener aperture 236 defines an aperture axis238, as best seen in FIG. 5, which is oriented obliquely relative to thefirst longitudinal axis 220.

Fastener aperture 236 is sized and configured to receive a bonefastener, such as an “Ortholoc® 3Di™” locking screw sold by WrightMedical Technology, Inc. of Memphis, which may be used to secure theextramedullary portion 230 to a bone section. In some embodiments, theaperture axis 238 is aligned obliquely with the longitudinal axis 220 asshown in FIG. 2. In other embodiments (not shown), the aperture axis 238is from about 90 degrees to about 180 degrees from the firstlongitudinal axis 220. For example, in some embodiments, the apertureaxis 238 is oriented orthogonal to the first longitudinal axis 220. Thebone fastener may be disposed transversely or obliquely, relative to thefastener aperture 236 and aperture axis 238. For example, in someembodiments, polyaxial screws can be inserted with an angle of 0.0 toabout 15 degrees from the aperture axis 238.

As best seen in FIG. 5, a flat surface 240 is formed along a face ofextramedullary portion 230 that is located on the opposite side ofimplant 200 as the contacting side or face 232. Flat or planar surface240 extends across extramedullary portion 230 and at least a portion ofintramedullary portion 210. In some embodiments, flat or planar surface240 is disposed parallel to bone contacting side or face 232, which ispositioned at an angle with respect longitudinal axis 220 such thatcontacting side or face 232 and flat surface 240 are not arrangedorthogonal or parallel to longitudinal axis 120. In some embodiments,the contacting side or face 232 and flat surface 240 are positioned atan angle of 15 degrees (or 165 degrees) relative to longitudinal axis220; however, a person of ordinary skill in the art will understand thatcontacting side or face 232 and flat or planar surface 240 may bedisposed at other angles (e.g., 5 degrees, 10 degrees, 20 degrees, etc.)relative to longitudinal axis 220 defined by intramedullary portion.

Implants 100, 200 can comprise a metal, such as titanium, stainlesssteel, or CoCr. In some embodiments, the implants 100, 200 can comprisea metal substrate coated with or having an additional layer ofhydroxyapatite (HA), titanium plasma spray (TPS)/vacuum plasma spray(VPS), roughened surface of resorbable blast media (RBM), a bioactiveglass, an antimicrobial or antibiotic, or strontium. Alternatively, theimplants 100, 200 can comprise a metal substrate with a compositecoating or composite layer including HA on plasma, beads, an irregularsintered coating or TPS on an RBM-prepared substrate. In otherembodiments, the metal substrate can have a porous coating. such asspherical bead, asymmetrical powder, or an irregular particle coating.

In some embodiments, the metal substrate of implants 100, 200 comprisesa degradable (resorbable) material, such as a magnesium alloy, which maycontain lithium, aluminum, rare earth metals (e.g., neodymium orcerium), manganese, zinc or other metals. In other embodiments, theresorbable material can include, but are not limited to polymermaterials including a polylactide, polyglycolide, polycaprolactone,polyvalerolactone, polycarbonates, polyhydroxy butyrates, poly orthoesters, polyurethanes, polyanhydrides, and combinations and copolymersthereof, for example. In some embodiments, implants 100, 200 comprise anon-absorbable polymer, such as polyethereetherketone (PEEK), or anabsorbable polymer composite, such as polylactic-acid (PLLA), aPLLA-beta-tricalcium-phosphate (β-TCP) blend, to list only a fewpossibilities.

In some embodiments, the implants 100, 200 comprise a biologic material.The biologic material can be a combination of Medical grade β-TCPgranules and rhPDGF-BB solution, such as “AUGMENT®” bone graft materialsold by Wright Medical Technology, Inc. of Memphis, Tenn. The biologicmaterial can be applied, sprayed, or inserted at the wound site for bonein-growth, or can be provided as a coating on the implants or any or allportions of the implant system. In some embodiments, the biologicmaterial is a coating containing osteoinductive or osteoconductivebiological components. In some embodiments, the biologic material caninclude bone morphogenetic factors, i.e., growth factors whose activityare specific to bone tissue including, but not limited to, demineralizedbone matrix (DBM), bone protein (BP), bone morphogenetic protein (BMP),and mixtures and combinations thereof. Additionally, formulations forpromoting the attachment of endogenous bone may comprise bone marrowaspirate, bone marrow concentrate, and mixtures and combinationsthereof.

The configuration of the implants 100, 200 advantageously provide anenhanced fixation of the distal fragment of the fifth metatarsalcompared to the conventional buttressing k-wire technique. Further, theability to use locking screws help prevent dorsal subluxation of thedistal fragment as compared to the buttressing k-wire technique.

Inserter

In some embodiments, an inserter 300 may be provided for aiding asurgeon or other individual in implanting one of the implants 100, 200in a patient. Such an inserter may be provided in a system or kit inaccordance with some embodiments. One example of an inserter 300 isillustrated in the various views provided in FIGS. 6-10. Referring firstto FIGS. 6-8, inserter 300 has a body 302 extending from a first end 304to a second end 306 and defining a longitudinal axis 308. In someembodiments, end 304 is an impacting or handle end and end 306 is anengagement end as described below.

As best seen in FIGS. 6 and 7, impacting end includes a flange 310 thatextends in a perpendicular direction with respect to the longitudinalaxis 308 defined by inserter 300. Flange 310 includes an impactingsurface 312, which is sized and structured to be impacted by a hand,mallet, hammer, or other impacting tool as will be understood by one ofordinary skill in the art. In some embodiments, flange 310 is supportedor reinforced by one or more reinforcing ribs 314. Reinforcing rib(s)314 may have triangular geometry as shown in FIG. 7, although othergeometric configurations also are possible.

As best seen in FIGS. 6 and 8, one or more indents 316 may be providedalong the length of the body 302. Indents 316 may be provided to enhancethe ability of a surgeon or other user to grasp and manipulate inserter300. In some embodiments, indents 316 have a rounded or curvedconfiguration to provide for enhanced ergonomics.

Engagement end 306 is structured to engage an implant 100, 200 anddefines a hole 318 (FIGS. 6, 8, and 9) and a pocket or channel 320(FIGS. 6, 9, and 10). In some embodiments, hole 318 is dimensioned toprovide clearance for receiving a mating end of a drill guide asdiscussed in greater detail herein. Pocket 320 is shaped and dimensionedto receive the enlarged head 134, 234 of extramedullary portion 130, 230therein such that, when the enlarged head 124, 234 is received withinpocket 320, the wall(s) 322 defining pocket 320 snugly engages the outersurface of enlarged head 134, 234 of implant 100, 200 to resist rotationof the implant 100, 200 relative to inserter 300.

As best seen in FIGS. 7 and 10, engagement end 306 may be angledrelative to the longitudinal axis 308 of inserter 300. In someembodiments, the angle of engagement end 306 corresponds to the angle ofthe extramedullary portion 130, 230 of the implant 100, 200. Further,hole 318 defines an axis 324 that is arrange on body 302 of inserter 300such that, when implant 100, 200 is engaged by engagement end 306 ofinserter 300, the axis 324 is aligned with aperture axis 138, 238.

In some embodiments and as best seen in FIGS. 6, 8, 9, and 10, inserter300 defines a hole or slot 330 along its length. The hole or slot 330 issized and structured to receive a k-wire therein to temporarily fixate adistal fragment to another bone, e.g., the fourth metatarsal, asdescribed in greater detail below. In some embodiments, an axis definedby hole or slot 330 is parallel to the axis 324 defined by hole 318.However, one of ordinary skill in the art will understand that hole orslot 330 may be oriented at other angles relative to the axis 324defined by hole 318.

Inserter 300 may be provided in a wide variety of materials, includingmetal and/or plastic. In some embodiments, inserter 300 is formed from amaterial that may be sterilized such that the inserter may be providedin a sterilized package along with one or more implants and/or otherdevices described herein.

Guide Tool

FIGS. 11-13 illustrate one example of a guide tool 400 in accordancewith some embodiments. Referring to FIG. 11, guide 400 includes a body402 that extends from a coupling end 404 to a second end 406. In someembodiments, the body 402 of guide 400 includes one or more shoulders410-1, 410-2 due to the body 402 including one or more segments of havea reduced diameter relative to an adjacent segment. As shown in FIG. 11,the guide 400 is provided with three body segments 402-1, 402-2, and402-3, with a shoulder 410-1 provided at the interface between bodysegments 402-1 and 402-2 and a shoulder 410-2 provided at the interfacebetween body segments 402-2 and 40-3. One of ordinary skill in the artwill understand that drill guide 400 may be provided with fewer segmentsand/or shoulders.

In some embodiments, distal segment 402-3 at coupling end 404 is atleast partially threaded. For example and as illustrated in FIG. 11,threads 408 may extend partially or entirely along segment 402-3. Bodysegment 402-2, which is disposed between body segment 402-1 and bodysegment 402-3, may be provided with a smooth external surface. In someembodiments, body segment 402-3 has a cross-sectional diameter that issized to be received within hole 318 of inserter 300 and has a thicknessor width of segment 402-3 (e.g., the distance between shoulder 410-2 andend 404) dimensioned relative to the depth of hole 318 defined byinserter 300 (e.g., the distance D1 in FIG. 10) such that shoulder 410-2is approximately planar with wall 328 of inserter 300 when the partiallythreaded portion of distal segment 402-3 is tightened onto the threadedaperture 136, 236.

Body segment 402-1, which in some embodiments has the greatestcross-sectional diameter, may include a surface texture formed on anexternal surface thereof to facilitate manipulate by a user. Forexample, the external surface 402-1 may include knurling, ridges,grooves, or any other suitable surface texturing as will be understoodby one of ordinary skill in the art.

As best seen in FIGS. 12 and 13, drill guide 400 defines a central guidehole 412 that extends through the entirety of body 402. Guide hole 412is sized and dimensioned to guide a suitable drill or other drilling orcutting tool for creating a pilot hole in a bone as discussed in greaterdetail below.

Broach

FIGS. 14-18 illustrate one example of a broach 500 including a handle502 and a blade insert 504, in accordance with some embodiments. Thehandle 502 includes a body 506 extending from a first end 510 to asecond end 512 substantially along a central longitudinal axis 514. Thehandle 502 defines at least one aperture 516 along its length extendingfrom a first (e.g., upper) surface 518 to the second (e.g., lower orbottom) surface 520. In some embodiments, the handle 502 defines a slotor channel (not shown) inwardly extending from a first end 512 into thebody 506 sized and configured to receive a portion of an insert 504therein. In some embodiments, the channel is sized and configured toreceive a portion of an insert 504 such that the aperture 516 is alignedwith apertures formed in the insert 504 (as described in greater detailbelow) when the insert 504 is inserted into the channel. In someembodiments, the insert 504 is over-molded by handle 502.

End 510 of body 502 includes a flange 520 that extends perpendicularlywith respect to the longitudinal axis 514 defined by body 502. Flange520 includes an impacting surface 522. Impacting surface 522 is sizedand structured to be impacted by a hand, mallet, hammer, or otherimpacting tool as will be understood by one of ordinary skill in theart. In some embodiments, flange 522 is supported or reinforced by oneor more reinforcing ribs 524. Reinforcing rib(s) 524 may have triangulargeometry as illustrated in FIG. 15, although a person of ordinary skillin the art will understand that other geometric configurations also arepossible.

As best seen in FIGS. 14 and 16, one or more indents 526 may be providedalong the length of the body 502. Indents 526 may be provided to enhancethe ability of a surgeon or other user to grasp and manipulate inserterbroach 500. In some embodiments, indents 500 have a rounded or curvedconfiguration to provide for enhanced ergonomics.

Turning now to FIGS. 17 and 18, one example of a blade or broach insert504 is illustrated in accordance with some embodiments. Insert 504includes a body 530 extending from a first end 532 to a second end 534substantially along a central longitudinal axis 536. The insert 504includes a first portion 538 configured to be coupled to a handle 502and a second portion 540 configured to be at least partially insertedinto a cut formed in a bone, such as a metatarsal, including the fifthmetatarsal. Aperture 542 is positioned along the length of body 530 andenables over-molding material to flow within aperture 542. In someembodiments, one or more additional apertures 548 are defined by body530 and are positioned along the body 530 of insert 504 such that, whenthe insert 504 is properly received within handle 502, apertures 548 arealigned with holes 516. The alignment of holes 516, 548 provides apassageway through broach 500 and enables a k-wire, pin, or other toolto be inserted through broach to provide some additional leverage for auser to dislodge broach from an intramedullary canal.

As shown in FIGS. 14-16, the insert 504 is configured to be coupled tothe handle 502 to define a broach 500 configured to assist in thepreparation of an intramedullary canal in a bone, such as a metatarsal,including a fifth metatarsal. As described in greater detail below, thesecond portion 540 of the insert 504 is configured to be inserted into abone and leveraged to offset a first portion of a bone with a secondportion of the bone to prepare an intramedullary canal. In someembodiments, a leading edge 550 of the insert 504 is configured tofacilitate insertion into the bone. The leading edge 550 can besharpened to define a cutting edge and/or include a thickness less thanthe thickness of the insert 504.

In some embodiments, the broach handle 502 (or a portion thereof) can beformed by injection molding material such as polycarbonate (PC),polyamide (e.g., Nylon), polyarylamide (e.g., PARA, Ixef, etc.),acrylonitrile butadiene styrene (ABS), and/or any other suitableinjection molding material. The injection molding can be formed over oneor more structural features, such as ribs, lattice, etc. or surfacefeatures, such as knurling, plasma spray, etc., to provide increasedstrength and/or to withstand forces applied during insertion of thebroach 500 and formation of an intramedullary canal in a bone. In someembodiments, the insert 504 (or a portion thereof) is formed of a metalmaterial formed by any suitable process, such as by stamping, bending,drilling, milling, turning, etc.

Assembly/System/Kit

In some embodiments, the implant 100, 200, inserter 300, and guide 400are provided in an assembled configuration, such as the configurationshown in FIG. 19. For example, the assembly 10 may be provided insterilized package with each component having been sterilized afterassemblage and packaging. As shown in FIG. 19, the extramedullaryportion 130, 230 of implant 100, 200 is received within pocket 320 ofinserter 300 such that intramedullary portion 110, 210 of implant isexposed by and extends away from end 306 of inserter 300.

More particularly, to provide the assembly 10, aperture hole 136, 236 ofimplant 100, 200 is aligned with hole 318 of inserter. Guide 400 isengaged with implant 100, 200 and inserter 300 by inserting body segment402-3 into the aligned holes 136 (or 236) and 318 and then engaging thethreads 408 of guide 400 with the thread segments 137 (or 237) of theimplant. In some embodiments, threads 408 of guide 400 are engaged withthread segments 137 (or 237) by rotating guide body 402 relative toimplant 100, 200 and inserter 300. The rotation of guide body 402 andthread engagement causes body 402 to advance into aperture 136 (or 236)and hole 318 of inserter 318 until shoulder 410-2 contacts the surface328 of inserter 300. Once fully engaged, the relative positions ofimplant 100, 200, inserter 300, and guide are fixed in the assembledconfiguration 10 shown in FIG. 19.

In some embodiments, the various implants and/or tools are provided in asurgical kit in which each of the various components is individuallyplaced within a sterilized package in a disassembled configuration andsterilized. For example, in some embodiments, one or more implants (ofvarious sizes) may be provided in the kit with a correspondingly sizedinserter, guide tool, and fastener(s). For example, the implant may beprovided in 2 mm, 3 mm, 4 mm, 5 mm, and other cross-sectional diameterswith inserters, guide tools, fasteners, and k-wire(s) configured forimplanting these implants. Systems may also be provided in which one ormore of the various components are separately packaged and then gatheredat the time of surgery as will be understood by one of ordinary skill inthe art. Various combinations of kits and/or individual components maybe gathered together to provide a system. One of ordinary skill in theart will understand that there are numerous ways to provide a kit,system, and/or assembly and the foregoing examples are not limiting.

Method of Use/Treatment Method

FIG. 20 is a flow chart of one example of a treatment method 600 inaccordance with some embodiments, with FIGS. 20A-20G illustratingvarious steps performed of the method. At block 602, a patient is placedin a supine position on an operating table, and the metaphysis of thefifth metatarsal (or other targeted bone or implant site) is identified.

At block 604, a longitudinal incision is made proximal from themetaphysis of the fifth metatarsal head M, as shown in FIG. 20A, andextending distally. In some embodiments, the periosteum around themetaphysis is elevated using an elevator to allow for extracapsularosteotomy.

In situations where a large lateral prominence of the metatarsal headexists, the lateral eminence may be shaved down at block 606. Thelateral eminence may be shaved down using a wedge burr or other suitablecutting or grinding tool as will be understood by one of ordinary skillin the art.

At block 608, an osteotomy is performed. In some embodiments, atransverse osteotomy is made using a Shannon burr B or saw at the levelof the metaphysis. For example, the burr B may be plunged bi-corticallyand then swept dorsally and plantarly to complete the cut. The plane ofthe cut may be perpendicular to the axis of the fifth metatarsal or tothe axis of the fourth metatarsal at the osteotomy site. In someembodiments, a chevron osteotomy is performed instead of a transverseosteotomy. FIG. 20B illustrates an osteotomy being performed using aburr B in accordance with some embodiments.

At block 610, the intramedullary canal of the proximal fragment PF isbroached. In some embodiments, an initial broaching of theintramedullary canal may be performed using an elevator E after havingmoved the distal fragment DF out of the way as shown in FIG. 20C. FIGS.20D and 20E illustrate the broach 500 being used to broach theintramedullary canal of proximal fragment PF. In some embodiments, amallet, hammer, or other impaction device (not shown) may be used toachieve the desired broaching as will be understood by one of ordinaryskill in the art. The impaction device may be used to hit impact surface522 of broach 500 until the distal end of the broach handle 512 nearlytouches the distal end of the proximal fragment PF. AP and MLradiographs may be checked to determine if the size of the broachadequately fills the intramedullary canal. If the broach does adequatelyfill the intramedullary canal, then the broach is removed. If the broachdoes not adequately fill the intramedullary canal, then a larger broachmay be selected and the steps at block 610 may be repeated.

At block 612, the implant 100, 200 is inserted into the broachedintramedullary canal. In some embodiments, the implant 100, 200 ispre-attached to inserter 300 and guide to provide the assembly 10 shownin FIG. 19 and as described above. The inserter 300 is used to guideimplant 100, 200 into the broached intramedullary canal with theinsertion end 106, 206 being introduced into the canal first as shown inFIG. 20F. A mallet (not shown) may be used to seat the implant 100, 200fully (or properly) within the broached intramedullary canal. Forexample, the mallet may be used to tap on the impact surface 312 ofinserter 300 until the inserter nearly touches the distal end of theproximal fragment.

At optional block 614, a k-wire may be inserted through the hole or slotdefined along the length of the inserter 300, through the distalfragment DF, and into a second bone, such as a fourth metatarsal. FIG.20G illustrates the k-wire K being inserted through a hole or slotformed in inserter 300 and passing through the distal fragment DF andinto second bone B2. In some embodiments, a surgeon may pinch mediallyof the distal fragment to ensure that the distal fragment is properlyaligned in the dorsal-plantar direction and that the distal fragmentlaterally contacts the implant 100, 200. This pinching may be performedprior to k-wire insertion and/or as the k-wire is inserted.

At block 616, drilling for placement of the distal fragment screw isperformed. For example, the distal fragment is drilled bi-corticallythrough the drill guide 400 as shown in FIG. 20H. In some embodiments,the drill guide 400 may be threaded directly into the thread segments137, 237 within the fastener aperture 136, 236 having removed theinserter 300. However, in some embodiments, the drilling may beperformed while the inserter 300 is still engaged with drill guide 400and implant 100, 200 as shown in FIG. 20H. Once drilling is complete,the drill guide 400 may be removed from its engagement with the assembly10 of the implant 100, 200 and inserter 300. Additionally, the inserter300 may be removed from its engagement with the implant 100, 200.

At block 618, a fastener 700 is selected and used to secure the implant100, 200 to the distal bone fragment DF. For example, a surgeon may usea locking or non-locking screw and inserts the selected fastener throughfastener aperture 136, 236 and into the pre-drilled bone fragment. Thek-wire K, if used, and inserter 300, if not yet removed, may then beremoved.

At block 620, the incision is closed. In some embodiments, thedistal-lateral corner of the proximal fragment is smoothed, using aburr, rasp, or other appropriate surgical tool, prior to closing theincision to avoid a sharp prominence after closure. One or more stitchesalso may be used to close the incision.

Although the subject matter has been described in terms of exemplaryembodiments, it is not limited thereto. Rather, the appended claimsshould be construed broadly, to include other variants and embodiments,which may be made by those skilled in the art.

What is claimed is:
 1. An implant comprising: a unitary body includingan intramedullary portion and an extramedullary portion, wherein theintramedullary portion is sized and structured to be received within anintramedullary canal of a first bone and defines a longitudinal axis,wherein the extramedullary portion includes a surface defining an axis,and the axis defined by the surface of the extramedullary portion isdisposed at an angle with respect to the longitudinal axis, and whereinthe extramedullary portion defines an aperture, the aperture sized andconfigured to receive a fastener therein for coupling the extramedullaryportion of the implant to a second bone.
 2. The implant of claim 1,wherein the fastener is one of a locking fastener and a non-lockingfastener.
 3. The implant of claim 1, wherein the extramedullary portiondefining the aperture includes surface features permitting a fastener tobe received at a plurality of angles relative to a central axis definedby the aperture.
 4. The implant of claim 3, wherein the surface featuresinclude a plurality of intermittent threads.
 5. The implant of claim 3,wherein the central axis defined by the aperture is positioned at anoblique angle with respect to the longitudinal axis defined by theintramedullary portion of the implant.
 6. The implant of claim 1,wherein the intramedullary portion has a circular cross-sectionalgeometry.
 6. The implant of claim 1, wherein a first end of theintramedullary portion of the implant tapers to a blunt end.
 7. Theimplant of claim 1, wherein a first end of the intramedullary portion ofthe implant tapers to a blade.
 9. The implant of claim 1, wherein theextramedullary portion of the implant is enlarged with respect to theintramedullary portion.
 10. The implant of claim 1, wherein theintramedullary portion of the implant includes one or more surfacefeatures disposed thereon for resisting rotation of the implant onceimplanted.
 11. The implant of claim 10, wherein the surface features areselected from a group consisting of threads, splines, fins, andknurling.
 12. The implant of claim 1, wherein the first bone is a firstbone fragment formed from a third bone, and the second bone is a secondbone fragment formed from the third bone.
 13. The implant of claim 1,wherein the first bone and the second bone are two adjacent bones of ajoint.
 14. A system, comprising: an implant, the implant comprising: aunitary body including an intramedullary portion and an extramedullaryportion, the intramedullary portion sized and structured to be receivedwithin an intramedullary canal of a first bone and defining alongitudinal axis, the extramedullary portion structured to be coupledto a second bone and defining an aperture and including a surfacedefining an axis, and the axis defined by the surface of theextramedullary portion is disposed at an angle with respect to thelongitudinal axis; and a fastener, the fastener sized and structured tobe received within the aperture defined by the extramedullary portion ofthe implant.
 15. The system of claim 14, wherein a central axis definedby the aperture is positioned at an oblique angle with respect to thelongitudinal axis defined by the intramedullary portion of the implant.16. The implant system of claim 14, wherein the surface of theextramedullary portion of the implant includes a planar surface.
 17. Theimplant system of claim 14, wherein the fastener is one of a lockingscrew and a non-locking screw.
 18. The implant system of claim 14,further comprising an inserter, the inserter comprising: a bodyextending from a first end to a second end, wherein at least one enddefines a pocket that is interconnected with a hole.
 19. The implantsystem of claim 18, wherein the pocket is sized, dimensioned, andstructured to receive at least a portion of the extramedullary portiontherein such that, when the extramedullary portion of the implant isreceived within the pocket, the hole defined by the inserter aligns withthe aperture defined by the implant.
 20. The implant system of claim 19,further comprising a guide, wherein the guide includes: a body extendingfrom a first end to a second end, the body defining a hole extendingthrough the body from the first end to the second end, wherein at leastone of the first end and the second end is at least partially threadedfor engaging a thread defined by the aperture defined by the implant.21. A treatment method, comprising: forming a longitudinal hole in afirst bone; inserting an intramedullary portion of an implant into thelongitudinal hole, the intramedullary portion defining a firstlongitudinal axis, the implant having an extramedullary portionconnected to the intramedullary portion, the extramedullary portiondefining an aperture and having a surface defining an axis that isdisposed at an angle with respect to the longitudinal axis defined bythe intramedullary portion; forming a hole in a second bone based on aposition of the aperture defined by the implant relative to the secondbone; inserting a fastener through the aperture and into the second boneto couple the extramedullary portion of the implant to the second bone.22. The method of claim 21, wherein forming the hole in the secondsegment in the bone includes: inserting a cutting tool into a guide holedefined by a guide, the guide being coupled to the implant such that theguide hole is aligned with the aperture defined by the implant; andfurther inserting the cutting tool into the guide hole until the cuttingtool engages the second bone.
 23. The method of claim 22, furthercomprising disengaging the guide from the implant prior to inserting thefastener through the aperture.
 24. The method of claim 21, furthercomprising disengaging an insertion tool from the implant prior toinserting the fastener through the aperture.
 25. The method of claim 21,wherein the longitudinal hole in the first bone is formed using abroach.
 26. The method of claim 21, wherein the first bone is a firstbone segment formed from a third bone, the second bone is a second bonesegment formed from the third bone, and the method includes performingan osteotomy on the third bone to form the first bone segment and thesecond bone segment.
 27. The method of claim 26, wherein the third boneis a fifth metatarsal.
 28. The method of claim 21, wherein the anglebetween the axis defined by the surface and the longitudinal axis is aright angle.